October 31, 2011: Foreign Site GMP Evidence Receipt Cut-Off Date

To: Drug Establishment Licence (DEL) Holders

As a result of the recent changes to the Establishment Licensing Regulations, the User Fees Act, and the commencement of the 2012 DEL annual review process, Health Canada is communicating the introduction of a new October 31, 2011 cut-off date for Health Canada to receive evidence to demonstrate drug GMP compliance for foreign sites to be considered during the annual review process. This new cut-off date along with more upfront screening [see the annual review package document entitled "Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)" for components required for a complete foreign site evidence package.], and the introduction of a submission "Administrative Hold"Footnote 1 process similar to that found in the management of drug submission review process, will assist Health Canada in meeting its new 250 day service standard timelines.

Specifically for the 2012 DEL annual review process:

Only those foreign sites identified in the 2012 DEL annual review submission package and for which Complete foreign site evidence has been received by October 31, 2011 will be considered for review as part of the 2012 DEL annual review. [See the 2012 DEL annual review package document entitled “Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)” for components required for a complete foreign site evidence package.].

Further, to the above,

if prior to the 2012 DEL annual review period you provided Health Canada with GMP evidence to support a foreign site’s addition to your 2012 DEL foreign site annex, you should include a note in your 2012 DEL annual review application indicating the date and to which Health Canada Unit/representative the information was forwarded.

if you wish to include a foreign site as part of your 2012 DEL annual review package for which complete foreign site evidence for that foreign site is not available at the time of application, please provide the reason and rationale for not submitting complete foreign site evidence for the foreign site. (Example: an inspection of the foreign site is currently taking place.)

Missing foreign site evidence to support a foreign site being added to the 2012 DEL foreign site annex as part of the annual review process will be accepted until October 31, 2011.

After October 31, 2011, if complete foreign site evidence has not been received, the foreign site will not be reviewed or considered for the 2012 DEL annual review and will not be added to the 2012 DEL foreign site annex. DEL holders will need to submit a new and separate foreign site application along with complete and acceptable GMP evidence, in order to add the foreign site to their 2012 DEL foreign site annex.

if the foreign site is located in a Mutual Recognition Agreement (MRA) country, this foreign site should be identified in the 2012 DEL annual review application documents. As per the MRA process, Health Canada will obtain the necessary GMP evidence via the associated regulatory authority.

It remains the case that foreign sites may be added to a DEL outside of the annual review process by submitting an application to amend the DEL, along with the required forms and complete GMP evidence.

Health Canada continues to encourage DEL holders to submit drug GMP evidence for foreign sites at any time through the year as soon as COMPLETE foreign site evidence is available, and not to wait for the annual review period. Partial packages of foreign site evidence are discouraged and will not be reviewed. Complete foreign site evidence that is not submitted as part of the annual review package, should be submitted to:

Footnotes

Administrative Hold: During the screening and processing of submitted DEL application information and material, it may be determined that the DEL application contents (e.g. fees, EL or GMP) are incomplete and additional information is required before the application may move forward in the licensing process. Health Canada will notify the applicant of the application deficiencies and will provide a deadline to submit a response. In such instances, the administrative review "clock" is stopped and the application is placed on "Administrative hold", until such time as a deficiency response is received.

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